Year-end spending bill: what's in and what's out

Among the provisions that made it into the Consolidated Appropriations Act 2023  — which must be enacted by Friday to avert a government shutdown — are authorities and requirements meant to strengthen the accelerated approval pathway and a mandate for companies to create clinical trial diversity plans.

The legislation would require FDA to specify post-approval study requirements by a therapy’s approval date, and it explicitly states that the agency “may require” confirmatory studies to be under way at the time of approval. It would stop short of requiring all post-approval studies be under way at approval. ...